On June 19, the UK’s National Institute for Health and Care Excellence (NICE) published its final draft guidance appraising the use of two new disease-modifying therapies for Alzheimer’s disease: lecanemab (marketed by Eisai and Biogen) and donanemab (marketed by Eli Lilly). Both drugs have been evaluated for treating adults with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease who are heterozygous for apolipoprotein E4 (APOE4) or non-carriers. Lecanemab was licenced by the UK's Medicines and Healthcare products Regulatory Agency in August 2024, followed a few months later by donanemab, which was licenced in October.
In NICE’s final guidance documents, which have been published after an extended consultation process, neither lecanemab nor donanemab are recommended for routine use or managed access in the National Health Service (NHS). While clinical trials (Clarity AD for lecanemab and TRAILBLAZER-ALZ for donanemab) showed that both drugs slowed cognitive decline compared to placebo, the benefits were considered modest. For example, lecanemab reduced clinical decline by 27–33% (on the CDR-SB scale of cognition and function) over 18 months, and donanemab by 23–29% (CDR-SB) over 76 weeks. While the NICE committee concluded that both drugs had clinically meaningful effects, the treatment effects were deemed to be small.
Cost-effectiveness was a key barrier. Both drugs require regular hospital infusions (every two weeks for lecanemab and every four weeks for donanemab), frequent MRIs, and intensive monitoring for side effects such as amyloid-related imaging abnormalities. NICE found that the cost per quality-adjusted life year (QALY) for each drug substantially exceeded the thresholds considered acceptable for NHS funding. NICE acknowledged the significant unmet need for disease-modifying therapies in Alzheimer’s disease and the considerable burden on patients and carers. However, it concluded that neither treatment currently offers sufficient value for NHS adoption. Further data on long-term benefits and improved cost-effectiveness would be required for reconsideration.
Responding, the Alzheimer’s Society expressed deep disappointment at the decision by NICE, calling for long-term investment in the NHS to fundamentally change dementia diagnosis - so healthcare systems are ready to deliver disease-modifying treatments such as lecanemab and donanemab, which rely on an early diagnosis and access to specialist diagnostic tests.
The draft guidance has been sent to consultees for this appraisal, who have 15 working days to consider whether they wish to appeal against it and/or notify NICE of any factual errors. Both Eisai and Eli Lilly have stated their intention to appeal against the decision.
Access the final NICE guidance documents:
Donanemab: https://www.nice.org.uk/guidance/indevelopment/gid-ta11221/documents
Lecanemab: https://www.nice.org.uk/guidance/indevelopment/gid-ta11220
